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Riabni

RITUXIMAB-ARRX

Manufacturer: Amgen Inc

Score: 144.0

Quick Summary

Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody used for the treatment of adult patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). It works by targeting the CD20 antigen on B-cells, leading to their depletion. The drug has shown efficacy in various clinical trials, but it also carries important safety warnings, including the risk of fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy. Dosing recommendations vary by condition, and special considerations are needed for certain populations, such as pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Treatment of adult patients with non-Hodgkin's lymphoma (NHL)
  • Treatment of adult patients with chronic lymphocytic leukemia (CLL)
  • Treatment of adult patients with rheumatoid arthritis (RA)
  • Treatment of adult patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)

Important Safety Information

Warning

Fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy

Contraindications

Adverse Reactions

  • Infusion-related reactions
  • Severe mucocutaneous reactions
  • Hepatitis B virus reactivation
  • Progressive multifocal leukoencephalopathy
  • Infections
  • Cardiovascular adverse reactions

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in certain situations, such as in patients with renal or hepatic impairment

NHL

Adult Dose

375 mg/m^2 as an intravenous infusion according to the following schedules

Pediatric Dose

Not established

CLL

Adult Dose

375 mg/m^2 the day prior to the initiation of FC chemotherapy, then 500 mg/m^2 on Day 1 of cycles 2-6

Pediatric Dose

Not established

RA

Adult Dose

Two 1000 mg intravenous infusions separated by 2 weeks

Pediatric Dose

Not established

GPA and MPA

Adult Dose

375 mg/m^2 once weekly for 4 weeks

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Rituximab products can cause adverse developmental outcomes, including B-cell lymphocytopenia in infants exposed in utero

Nursing Mothers

  • It is not known whether rituximab is excreted in human milk

Pediatric Use

  • The safety and effectiveness of rituximab products have not been established in pediatric patients less than 2 years of age for GPA and MPA
  • The safety and effectiveness of rituximab products have not been established in pediatric patients with CLL

Geriatric Use

  • No overall differences in efficacy were observed between patients 65 years old and over and younger patients
  • The overall incidence and rate of all serious adverse events was higher in patients 65 years old and over